US2019083642A1PendingUtilityA1

Treatments utilizing a polymer-protein conjugate

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Assignee: REGENTIS BIOMATERIALS LTDPriority: Mar 30, 2016Filed: Mar 30, 2017Published: Mar 21, 2019
Est. expiryMar 30, 2036(~9.7 yrs left)· nominal 20-yr term from priority
Inventors:Yonatan ShachafAharon Wechsler
A61L 2430/06A61L 2430/02A61P 19/02A61P 19/04A61K 9/08A61K 31/728A61K 47/6435A61K 9/0019A61L 27/52A61K 47/6903A61K 47/60A61K 47/59A61L 27/18A61L 27/54A61L 27/50C12N 15/87A61K 45/06
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Claims

Abstract

A composition for use in treating a condition associated with degeneration of articular cartilage and/or with subchondral bone loss is disclosed herein. The composition comprises a conjugate which comprises a polypeptide having attached thereto at least two polymeric moieties, at least one of the polymeric moieties exhibiting a reverse thermal gelation. Further disclosed is a composition comprising the aforementioned conjugate along with a hyaluronic acid, an anti-inflammatory agent, an analgesic, a growth factor, a blood fraction, a nucleic acid, and/or a cell, the composition being an aqueous composition which forms a hydrogel at a temperature in a range of from 32° C. to 37° C., as well as a method utilizing such a composition comprising a nucleic acid for effecting gene delivery.

Claims

exact text as granted — not AI-modified
1 . A method of treating a condition associated with degeneration of articular cartilage and/or with subchondral bone loss in a subject in need thereof, the method comprising administering to the subject a composition comprising a conjugate which comprises a polypeptide having attached thereto at least two polymeric moieties, at least one of said polymeric moieties exhibiting a reverse thermal gelation, thereby treating the condition. 
     
     
         2 . The method of  claim 1 , comprising intra-articular administration of the composition. 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein said degeneration is associated with friction at a surface of said articular cartilage. 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 1 , wherein said degeneration of articular cartilage and/or said subchondral bone loss is associated with an inflammation. 
     
     
         7 . The method of  claim 1 , wherein said condition is associated with a subchondral bone cyst. 
     
     
         8 . (canceled) 
     
     
         9 . The method of  claim 1 , wherein the composition is characterized by water uptake of less than 20 weight percents upon incubation with an aqueous liquid for 48 hours at a temperature of 37° C. 
     
     
         10 . The method of  claim 1 , wherein the composition comprises an aqueous solution of said conjugate. 
     
     
         11 . (canceled) 
     
     
         12 . The method of  claim 1 , wherein the composition is capable of undergoing a reverse thermal gelation. 
     
     
         13 . The method of  claim 1 , wherein the composition further comprises at least one additional therapeutically active agent. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 1 , wherein said condition is arthritis. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 1 , wherein at least a portion of said articular cartilage and/or said subchondral bone is in a synovial joint. 
     
     
         18 . The method of  claim 1 , wherein said polypeptide is at least 20 amino acids in length. 
     
     
         19 . The method of  claim 1 , wherein said polypeptide is capable of adhering to cartilage. 
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 1 , wherein said polypeptide comprises a protein or a fragment thereof. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 1 , wherein each of said polymeric moieties exhibits a reverse thermal gelation. 
     
     
         24 - 25 . (canceled) 
     
     
         26 . The method of  claim 1 , wherein at least one of said polymeric moieties further comprises at least one cross-linking moiety capable of covalently cross-linking said conjugate with a protein in vivo. 
     
     
         27 . A pharmaceutical composition comprising:
 a conjugate which comprises a polypeptide having attached thereto at least two polymeric moieties, at least one of said polymeric moieties exhibiting a reverse thermal gelation; and   at least one additional therapeutically active agent selected from the group consisting of a hyaluronic acid, a blood fraction, and a cell,   the composition being an aqueous composition which forms a hydrogel at a temperature in a range of from 32° C. to 37° C.   
     
     
         28 . (canceled) 
     
     
         29 . The composition of  claim 27 , being characterized by water uptake of less than 20 weight percents upon incubation with an aqueous liquid for 48 hours at a temperature of 37° C. 
     
     
         30 . (canceled) 
     
     
         31 . The composition of  claim 27 , being capable of undergoing a reverse thermal gelation. 
     
     
         32 . The composition of  claim 27 , wherein at least 20 weight percents of the composition is said blood fraction. 
     
     
         33 . (canceled) 
     
     
         34 . The composition of  claim 27 , wherein said polypeptide is at least 20 amino acids in length. 
     
     
         35 . The composition of  claim 27 , wherein said polypeptide comprises a protein or a fragment thereof. 
     
     
         36 . (canceled) 
     
     
         37 . The composition of  claim 27 , wherein each of said polymeric moieties exhibits a reverse thermal gelation. 
     
     
         38 - 39 . (canceled) 
     
     
         40 . The composition of  claim 27 , wherein at least one of said polymeric moieties further comprises at least one cross-linking moiety capable of covalently cross-linking said conjugate with a protein in vivo. 
     
     
         41 . The composition of  claim 27 , being an injectable composition. 
     
     
         42 . (canceled) 
     
     
         43 . A method of treating a condition in a subject in need thereof, the method comprising administering to the subject the composition of  claim 27 , wherein said condition is treatable by said therapeutically active agent, thereby treating the condition. 
     
     
         44 . The method of  claim 43 , wherein said condition is treatable by local administration of said therapeutically active agent, and the method comprises local administration of the composition. 
     
     
         45 . The method of  claim 43 , wherein said at least one therapeutically active agent comprises said blood fraction, and said condition is selected from the group consisting of arthritis, nerve injury, tendinitis, muscle injury, bone injury, and surgical injury. 
     
     
         46 . (canceled) 
     
     
         47 . The method of  claim 43 , wherein said at least one therapeutically active agent comprises said hyaluronic acid, and said condition is arthritis. 
     
     
         48 . A method of effecting gene delivery, the method comprising contacting at least one cell with athe composition comprising:
 a conjugate which comprises a polypeptide having attached thereto at least two polymeric moieties, at least one of said polymeric moieties comprising a poloxamer (poly(ethylene oxide-propylene oxide) copolymer) and exhibiting a reverse thermal gelation; and   a nucleic acid comprising said gene,   the composition being an aqueous composition which forms a hydrogel at a temperature in a range of from 32° C. to 37° C.,   thereby effecting delivery of said gene to said at least one cell.   
     
     
         49 - 50 . (canceled).

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